Recalls / —
—#86930
Product
Cordis Aquatrack Hydrophilic Nitinol Guidewire, for use in angiographic procedures, REF C3526-SSA, Guidewire Diameter .035" Tip Length Flexible 3 cm, Sterile. Contents 5 Hydrophilic guidewires and torquing devices.
- FDA product code
- DQX — Wire, Guide, Catheter
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K011905
- Affected lot / code info
- Lots 80000521 and 80000584
Why it was recalled
Some of the guidewires in these two lots have a straight tip (incorrect) rather than an angled tip (correct configuration for that catalog number).
Root cause (FDA determination)
Process control
Action the firm took
Recall for Lot 80000521 was initiated on August 25, 2009 with Cordis Medical Device Recall letters being mailed for delivery on August 25, 2009. Response form was also provided to obtain product disposition. Recall for Lot 80000584 was initiated on October 19, 2009 with Cordis Medical Device Recall letters being mailed for delivery on October 20, 2009. Response form was also provided to obtain product disposition.
Recalling firm
- Firm
- Cordis Corporation
- Address
- 14201 Nw 60th Ave, Miami Lakes, Florida 33014-2802
Distribution
- Distribution pattern
- Nationwide distribution.
Timeline
- Recall initiated
- 2009-08-25
- Posted by FDA
- 2010-01-13
- Terminated
- 2010-08-11
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #86930. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.